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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K953749
Device Name MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS
Applicant
Curwood, Inc.
2200 Badger Ave.
Oshkosh,  WI  54904
Applicant Contact MATTHEW A MIELKE
Correspondent
Curwood, Inc.
2200 Badger Ave.
Oshkosh,  WI  54904
Correspondent Contact MATTHEW A MIELKE
Regulation Number880.6850
Classification Product Code
KCT  
Date Received08/11/1995
Decision Date 10/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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